The role of the Auditor, Clinical Quality and Compliance is to perform audit-as per the audit plans, assessing/securing compliance in study conduct.

This role will be perfect for you if:

• You approach challenges with an understanding of norms and regulations, combined with a creative and inquisitive mind
• You enjoy working with a small team, contributing your experience and expertise to complete a variety of tasks , including special projects
• You love being part of different types of audits

RESPONSABILITIES

More specifically, the Auditor, Clinical Quality and Compliance will:

• Execute the audits in accordance with the established audit program and the study-specific audit plan.
• Perform audit activities such as planning, conduct and report writing (sites, studies, internal and vendors). Takes a risk-based approach for the sampling verifications to be performed.
• Can facilitate audit planning and conduct when external consultant is involved.
• Issue observations/recommendations and review appropriateness of audit responses/CAPA plan and track the progress.
• Review and assess non-compliances, adequacy of CAPA plan and track the progress of action items. Can participate to investigations where needed.
• Contribute to GxP consultation.
• Participate in sponsor study-specific audits and regulatory inspections including mock inspection activities.
• Work closely with the Quality System group for internal, vendor audits and periodic risk review of vendors. Can also be involved in client’s qualification audits and review of SOPs.
• Contribute to training content for topics related to SOP, regulations and GxP. Can provide training to Indero's employees.

Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.

Requirements:

Education

• Bachelor degree in a relevant discipline or equivalent experience;

Experience

• minimum of 3 years’ experience in the pharmaceutical or research industry (more specifically in clinical quality)

Knowledge and skills

• Excellent knowledge of ICH guidelines, FDA and Health Canada regulations. Good knowledge of EU standards.
• Master the overall audit process including a systems-oriented approach, investigation/root cause determination and CAPA process.
• Ability to communicate effectively both orally and in writing;
• Good organization skill and ability to adapt to a rapidly growing environment;
• Bilingual: French and English, written and spoken;
• Good knowledge of the Microsoft Office Suite (Word, Excel, PowerPoint);
• Willing to travel 10-30% of the time

Brand name:
Indero

Our company:

The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

• Flexible work schedule / work schedule
• Home-based position
• Benefits
• RRSP
• Ongoing learning and development

About Indero

Indero is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Canada.

Description de poste:

Le rôle de l’auditeur, Qualité clinique et conformité, est de réaliser des audits conformément aux plans d’audit, afin d’évaluer et d’assurer la conformité dans la conduite des études.

Ce poste vous conviendra parfaitement si :

• Vous abordez les défis avec une compréhension des normes et des règlements, combinée à un esprit créatif et curieux
• Vous aimez mettre à profit votre expérience et votre expertise afin d'accomplir une variété de tâches, y compris des projets spéciaux
• Vous aimez être exposé à différents types d'audits

RESPONSABILITÉS

Plus spécifiquement, l’Auditeur, qualité Clinique et conformité doit:

• Exécuter les audits conformément au programme d’audit établi et au plan d’audit spécifique à l’étude.
• Réaliser les activités d’audit, incluant la planification, la conduite et la rédaction des rapports (sites, études, audits internes et fournisseurs). Adopter une approche fondée sur le risque pour les vérifications par échantillonnage à effectuer.
• Faciliter la planification et la réalisation des audits lorsque des consultants externes sont impliqués.
• Émettre des observations et des recommandations, examiner la pertinence des réponses aux audits et des plans